Respiratory syncytial virus (RSV) lower respiratory tract disease

Active Ingredient: Clesrovimab

Indication for Clesrovimab

Population group: only newborns (0 - 40 days old) , infants (40 days - 1 year old)
Therapeutic intent: Preventive action

Clesrovimab is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season.

Clesrovimab should be used in accordance with official recommendations.

For this indication, competent medicine agencies globally authorize below treatments:

105 mg once

For:

Dosage regimens

Intramuscular, 105 milligrams clesrovimab, one dose.

Detailed description

Neonates and infants: first RSV season

The recommended dose is 105 mg administered as a single 0.7 mL intramuscular (IM) injection.

For neonates and infants born during the RSV season, clesrovimab should be administered starting from birth. For infants born outside the RSV season, it should be administered once prior to the start of their first RSV season.

Dosing in infants with a body weight between 0.5 kg and 1.1 kg is based on extrapolation; no clinical data are available. Exposure in infants <1.1 kg is anticipated to yield higher exposures than in those weighing more. The benefits and risks of clesrovimab in infants <1.1 kg should be carefully considered.

There are limited clinical data available in extremely preterm infants (gestational age (GA) <29 weeks) who are of chronological age less than 8 weeks. No clinical data are available in infants with a postmenstrual age (GA plus chronological age) of less than 32 weeks.

Infants undergoing cardiac surgery with cardiopulmonary bypass

For infants undergoing cardiac surgery with cardiopulmonary bypass during the RSV season, an additional 105 mg dose is recommended as soon as the infant is stable after surgery to ensure adequate clesrovimab serum levels.

Dosage considerations

Clesrovimab injection should be administered intramuscularly by a healthcare professional, in the anterolateral aspect of the thigh. It should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel.

Active ingredient

Clesrovimab

Clesrovimab is a fully human immunoglobulin G1 kappa (IgG1κ) neutralising monoclonal antibody with a triple amino acid substitution (YTE) in the Fc region which increases binding to the neonatal Fc receptor leading to an extended serum half-life. Clesrovimab provides passive immunity by targeting the RSV outer membrane fusion (F) protein to prevent viral entry into cells.

Read more about Clesrovimab

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